Efficacy of Chuanxiong Ding Tong Herbal Formula Granule in the Treatment and Prophylactic of Migraine Patients: A Randomized, Double-Blind, Multicenter, Placebo-Controlled Trial
Table 1
Baseline characteristics of the study participants and primary outcome measures (PPS, ).
CXDT-HFG group ()
Placebo group ()
values
Mean ± SD
95% CI
Mean ± SD
95% CI
Age, years
35.77 ± 11.60
(33.28, 38.25)
34.58 ± 9.85
(31.52, 37.65)
0.738
Sex
Male, (%)#
23 (26.7%)
—
11 (26.2%)
—
0.947
Female, (%)
63 (73.3%)
—
31 (73.8%)
—
—
Course of disease (months)
86.26 ± 88.10
(67.37, 105.14)
82.12 ± 72.76
(59.45, 104.79)
0.716
Migraine days§
Baseline
4.48 ± 4.12
(3.59, 5.36)
4.13 ± 4.33
(2.78, 5.47)
0.572
4 w
4.01 ± 5.11
(2.92, 5.11)
2.88 ± 2.05
(2.24, 3.52)
0.548
Improvement from baseline
−0.46 ± 4.36
(−1.40, 0.47)
−1.25 ± 4.89
(−2.77, 0.28)
0.755
8 w
2.41 ± 3.34
(1.69, 3.12)
1.93 ± 1.52
(1.45, 2.40)
0.848
Improvement from baseline
−2.07 ± 4.42
(−3.01, −1.12)
−2.20 ± 4.77
(−3.68, −0.71)
0.438
12 w
1.44 ± 3.22
(0.75, 3.22)
1.93 ± 2.28
(1.22, 2.64)
0.054
Improvement from baseline
−3.04 ± 5.12
(−4.13, −1.93)
−2.20 ± 4.95
(−3.74, −0.66)
Follow-up period
1.06 ± 3.13
(0.39, 1.73)
1.69 ± 2.35
(0.96, 2.42)
0.019‡
Improvement from baseline
−3.42 ± 5.04
(−4.49, −2.34)
−2.44 ± 4.94
(−3.97, −0.90)
0.042△
Migraine attack frequency§
Baseline
3.82 ± 2.16
(3.36, 4.28)
3.91 ± 4.32
(2.57, 5.26)
0.350
4 w
2.55 ± 2.00
(2.12, 2.97)
2.12 ± 1.21
(1.74, 2.50)
0.430
Improvement from baseline
−1.27 ± 1.63
(−1.62, −0.92)
−1.79 ± 4.52
(−3.20, −0.39)
0.641
8 w
1.74 ± 1.57
(1.41, 2.08)
1.52 ± 1.13
(1.17, 1.88)
0.686
Improvement from baseline
−2.07 ± 2.03
(−2.51, −1.64)
−2.39 ± 4.65
(−3.84, −0.94)
0.404
12 w
0.98 ± 1.35
(0.69, 1.27)
1.24 ± 1.08
(0.90, 1.57)
0.085
Improvement from baseline
−2.84 ± 2.36
(−3.35, −2.33)
−2.67 ± 4.60
(−4.11, −1.24)
0.043△
Follow-up period
0.74 ± 1.32
(0.46, 1.03)
1.19 ± 1.35
(0.77, 1.61)
0.033‡
Improvement from baseline
−3.08 ± 2.32
(−3.57, −2.58)
−2.72 ± 4.63
(−4.17, −1.28)
0.033△
Acute pain drug consumption (times)§
Baseline
0.62 ± 1.33
(0.33, 0.91)
0.49 ± 1.10
(0.15, 0.83)
0.506
4 w
0.35 ± 1.19
(0.09, 0.60)
0.26 ± 0.83
(0.00, 0.52)
0.888
8 w
0.17 ± 0.93
(−0.02, 0.38)
0.12 ± 0.45
(−0.02, 0.26)
0.627
12 w
0.08 ± 0.47
(−0.02, 0.19)
0.14 ± 0.57
(−0.03, 0.32)
0.371
Follow-up period
0.02 ± 0.15
(−0.01, 0.06)
0.21 ± 0.75
(−0.02, 0.45)
0.066
Responder rate (migraine days)#
12 w
62 (72.1%)
—
28 (66.7%)
—
0.528
Follow-up period
72 (83.7%)
—
27 (64.3%)
—
0.014‡
Responder rate (attack frequency)#
12 w
70 (81.4%)
—
29 (69.0%)
—
0.117
Follow-up period
75 (87.2%)
—
31 (73.8%)
—
0.059
w: weeks. CI: confidence interval; PPS: per-protocol sets; significant difference, . Data presented as mean ± SD, number (percentage) and 95% CI. for comparison with control group.
# values based on Chi-square test. § values based on repeated measures. ‡, for date comparison between groups. △, for value from baseline comparison between groups.
